Device product
RENASYS EDGE 800ML CANISTER WITH Solidifier- Indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing Product Number: 66803140
Z-1597-2024
Product summary
- Event
- Event 94248
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 675 units
- Official record key
device-enforcement:Z-1597-2024
Official wording
Reason: Black particulate matter from the carbon filter component of the canisters entering the NPWT pump and potentially causing damage to the pump
Code information: GTIN: (01)05000223501082 Lot Numbers: 1016051, 1017549
Distribution pattern: Worldwide distribution - US Nationwide and the countries of Canada, Chile.
Derived failure modes
-
Foreign material or chemical contamination
particulate matter